Shakeel Sadia, Iffat Wajiha, Nesar Shagufta, Zaidi Hina, Jamshed Shazia
Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, University Sains Malaysia, Penang, Malaysia.
Faculty of Pharmaceutical Sciences, Dow University of Health Sciences, Karachi, Pakistan.
Integr Pharm Res Pract. 2020 Feb 5;9:33-39. doi: 10.2147/IPRP.S231134. eCollection 2020.
A cross-sectional study was carried out to evaluate the practice of unlicensed and off-label drug prescribing/dispensing in children and neonates by physicians and clinical pharmacists in the metropolitan city of Karachi.
The study was conducted for the duration of 5 months - November 2018 to March 2019 - in different clinics and tertiary care hospitals of Karachi, Pakistan. Respondents were interviewed by our researchers using 30 items questionnaire. Descriptive statistics were used to evaluate the answers of respondents to survey items. Pearson correlation and independent sample -test were employed to recognize the association between the responses of participants and independent variables. P values less than 0.05 were considered statistically significant.
A total of 421 questionnaires were completed by physicians and clinical pharmacists. The mean age of the study participants was 49.5 years. Around 98% of pharmacists and 93.5% of physicians were well conversant with the definition of unlicensed and off-label drugs. Around 68% of physicians and 77% of pharmacists reported that they were more concerned about the efficacy of such drugs as compared to that of licensed medicines in children. The most frequent off-label categories observed in the study were dose (65.21%) and indication (17.52%). A vast majority (>80%) thought that approving new drugs by regulatory authorities will drop the occurrence of medication errors due to incorrect dosing. The British National Formulary (BNF) for children was used as the best reliable source of information among respondents.
The present study highlighted the common practice of unlicensed and off-label drug prescribing in pediatrics; however, respondents showed their concern towards decreasing such practice and are likely to welcome initiatives intended to assure medication safety in children.
开展一项横断面研究，以评估卡拉奇市的医生和临床药剂师在儿童及新生儿中开具/调配未获许可及超说明书用药的情况。
该研究于2018年11月至2019年3月期间，在巴基斯坦卡拉奇市的不同诊所和三级医疗机构进行，为期5个月。研究人员使用一份包含30个条目的问卷对受访者进行访谈。描述性统计用于评估受访者对调查项目的回答。采用Pearson相关性分析和独立样本检验来确定参与者的回答与自变量之间的关联。P值小于0.05被认为具有统计学意义。
医生和临床药剂师共完成了421份问卷。研究参与者的平均年龄为49.5岁。约98%的药剂师和93.5%的医生非常熟悉未获许可及超说明书用药的定义。约68%的医生和77%的药剂师报告称，与儿童使用的已获许可药物相比，他们更关注此类药物的疗效。研究中观察到最常见的超说明书用药类别是剂量（65.21%）和适应证（17.52%）。绝大多数（>80%）人认为监管机构批准新药将减少因用药剂量错误导致的用药差错。在受访者中，《英国国家儿童处方集》（BNF）被视为最可靠的信息来源。
本研究突出了儿科中开具未获许可及超说明书用药的普遍情况；然而，受访者对减少此类情况表示关注，并可能欢迎旨在确保儿童用药安全的举措。
